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510(k) K874658

TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) by Technicon Instruments Corp. — Product Code CEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1987
Date Received
November 12, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroxine-Binding Globulin
Device Class
Class II
Regulation Number
862.1685
Review Panel
CH
Submission Type

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